UNIT-II Qualification and Validation.pptx

Qualification and validation of facilities, equipment, systems and procedures are essential to demonstrate that all critical stages of the transfer project have been completed successfully, enabling the RU to reproduce the product, process or method routinely to the specifications agreed with the SU.

1. UNIT-II Qualification and Validation COURSE: B.PHARM IV YEAR, VII SEM SUBJECT: INDUSTRIAL PHARMACY-II COURSE CODE: BP-702 T PREPARED BY MS. RAMANDEEP KAUR ASSISTANT PROFESSOR PHARMACY ACADEMY IFTM UNIVERSITY, MORADABAD, UP

2. Qualification and Validation General Qualification and validation of facilities, equipment, systems and procedures are essential to demonstrate that all critical stages of the transfer project have been completed successfully, enabling the RU to reproduce the product, process or method routinely to the specifications agreed with the SU. Validation performed as part of the transfer project should be documented in a validation master plan (VMP). The VMP should identify the stages which need to be validated and define acceptance criteria. For intra-company transfers, the RU should operate under the same VMP as the SU. For intercompany transfers, a VMP should be in place at the RU before the transfer. The RU should prepare a validation protocol (VP) for each sequential step. Successful execution of each VP should be documented in a validation report (VR).

3. Setting up and commissioning of systems at the RU need to be completed before qualification and validation can be performed at the RU. The steps required for this purpose have been described in this guideline for buildings, services and equipment, manufacturing, packaging and cleaning and analytical testing. In brief, the following basic steps apply equally to each of these areas: the SU should provide information on materials, systems and procedures involved in the manufacturing of the product, process or method to be transferred; the RU should review the information provided by the SU, and audit its current systems, equipment and processes, including non-process related practices and support services that impact the process; based on this review, the RU should either accept the information provided or develop it further to prepare site-specific procedures, SOPs, training programmes and protocols which will form the basis of the qualification and validation; and relevant staff, e.g. operators and analysts, should be trained in any new processes as required.

4. Once the required systems and procedures have been commissioned at the RU, and successful training has been documented, qualification and validation of facility and equipment should be executed, followed by validation of analytical test methods, process validation for manufacturing and packaging, and cleaning validation. The RU should review the gap analysis and prepare, where appropriate, VPs for the facility, services and equipment. Both new and existing equipment should satisfy the VPs associated with purchase and design specifications, factory acceptance tests (FAT) if possible, IQ and OQ. Performance qualification, including a further assessment of operating parameters with relation to product characteristics, should be established on commencement of trial batches. Successful completion of qualification and validation should be documented in a report.

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